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Trial Capabilities Manager - Asia Pacific Region

Taiwan

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Req ID R-2385 Title Trial Capabilities Manager - Asia Pacific Region City TAIPEI State / Province Taipei City Country Taiwan

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

We’ve received recognition from several distinguished organizations for our efforts. Here are some of our honors in recent years:

  • Catalyst Award, for our innovative Employee Journeys and People Strategy
  • Corporate Knights, Global 100 Most Sustainable Corporations in the World
  • Ethisphere, World's Most Ethical Companies 2019 – 3rd year in a row
  • Forbes, America's Best Employers for Diversity

About Lilly Taiwan

Here at Lilly, we are focused on our common purpose to make life better for people around the world. Whether here in Taiwan, the greater NAPAC region, or our corporate headquarters in Indianapolis, each team member plays a critical role in ensuring we deliver on that purpose.

The Lilly Taiwan team is an exciting and fulfilling place, where we work hard to change lives for patients while supporting and encouraging each other to be and bring our best. Lilly is a place you can grow and lead, innovate, connect with coworkers who care about you and find meaning in the work you do. Join us.

Responsibility:

The Trial Capabilities Manager leads the clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. This includes submission of documents to regulatory authorities and Ethics Review Boards, serve as the point of contact for a site’s Ethics Review Board and Competent Authority (where applicable), assist in budget and contract negotiation. The manager is accountable for the prioritization, planning and implementation of site initiation activities working closely with the site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritization and timely execution to meet portfolio needs.

The manager provides leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives. The manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. Clinical Trial Capabilities Responsibilities

  • Accountable for meeting and exceeding goals for clinical trial initiation for development programs
  • Accountable for ensuring site activation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards
  • Effective communication and negotiation of budget and contract management
  • Effective oversight on managing investigator payments and any other financial transactions related to Trial
  • Capabilities which include, but not limited to, vendor creation and management, PO creation and maintenance, payment activities, country/site budget tracking, and payment-related issue resolution
  • Drive and ensure Site Activation strategies are created and delivered
  • Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners
  • Accountable for prioritization of work to meet portfolio needs
  • Ensure flexibility of resources across trial capabilities teams, and geographies (as applicable)
  • Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements
  • Develop and manage strategies to improve customer experience
  • Ensure inspection readiness through a complete, accurate and readily available Trial Master File
  • Strategic prioritization and use of internal system to ensure accuracy of trial/site performance (e.g. PCE/CCPM)
  • Accountable to audit and inspection responses and corrective action plans that under affiliate Trial Capabilities’ responsibilities
  • Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)

2. Organizational Leadership

  • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO and MDU
  • Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Clinical Information and Process Automation to leverage technology to increase efficiency of clinical trial capabilities and resources (insert purpose of the role) 
  • Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning
  • Manage staff compliance to local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)

3. People Management and Development

  • Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical
  • development
  • Effectively manage an agile organization that continuously meets the needs of a changing portfolio
  • Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery

Qualifications:

  • Bachelor’s degree preferably in a scientific or health related field
  • Five (5) years clinical research experience or relevant experience
  • Leadership experience

Additional Skills/Preferences

  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Experience in coaching and mentoring others
  • Applied knowledge of project management processes and skills
  • Experience in compliance-driven environment
  • Strong communication, negotiation, and problem-solving skills
  • Language Capabilities – English (read, write, conversation) and local language, as applicable

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-2385.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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